bile duct cancer
Conditions
Interventions
In part one a maximum of 15 patients will receive a single bolus injection of
bevacizumab-800CW three days before surgery. During surgery, several imaging
moments are defined in which the near infra
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age older or equal to 18 year - Patients with suspected perihilar cholangiocarcinoma who are scheduled to undergo surgical intervention with curative intent - WHO performance score 0-2
Exclusion criteria
Exclusion criteria: - Medical or psychiatric conditions that compromise the patient's ability to give informed consent. - Other invasive malignancy - Pregnant or lactating women. - History of infusion reactions to bevacizumab - Inadequately controlled hypertension with or without current antihypertensive medications - Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Standard histopathological examination to confirm higher fluorescent signals in tumour tissue compared to normal tissue. - Calculating target to background ratios in fluorescence images obtained during and directly after the surgical procedure and fluorescence images obtained during ex vivo analyses in bread loaf slices and in histological slices (odyssey scanner, fluorescence microscopy). - Determining the tracer distribution at microscopic level using needle based confocal laser endomicroscopy during ex vivo off table imaging. - Measuring fluorescent signal using spectroscopy to correct for scattering. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Intraoperative assessment of positive margins based on fluorescent images. - Off table imaging of surgical specimen directly after excision to identify positive margins, lymph nodes and metastases based on ex vivo fluorescent images. - Back table imaging of surgical specimen after excision to identify tumour tissue by NIR endoscopy based on ex vivo fluorescent images . | — |
Countries
Netherlands
Outcome results
None listed